Phase 1 TAK-906 Single and Multiple Ascending Dose Study in Japanese Healthy Male Participants

NCT03237156 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: TAK-906-1004U1111-1197-9663JapicCTI-173661
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of TAK-906 in Japanese healthy male participants.

Conditions

Japanese Healthy Adult Male Participants

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (5)

• Number of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE)

  An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with the treatment or study participation. A treatment-emergent adverse events (TEAE) is defined as an AE whose date of onset occurs on or after the start of study drug.

  Baseline up to Day 14

• Number of Participants With Markedly Abnormal Values of Vital Signs

  Reported data were numbers of participants who met markedly abnormal criteria of vital signs. Vital signs included body temperature, respiratory rate, blood pressure, and pulse. Vital signs collected were classified as markedly abnormal values if they met the following criteria: systolic blood pressure less than (\<) 85 millimeter of mercury (mmHg) or greater than (\>) 180 mmHg, diastolic blood pressure \<50 mmHg or \>110 mmHg, pulse \<50 beats per minute (bpm) or \>120 bpm, body temperature \<35.6 °C or \>37.7 °C.

  Baseline up to Day 14

• Number of Participants With Markedly Abnormal Values of Clinical Laboratory Test Results

  Reported data were numbers of participants who met markedly abnormal criteria of clinical laboratory test results. Clinical laboratory test results collected were classified as markedly abnormal values if they met the following criteria: red blood cells \<0.8×lower limit of normal (LLN) or \>1.2×upper limit of normal (ULN), platelets \<75×10\^3/μL or \>600×10\^3/μL, white blood cells \<0.5×LLN or \>1.5×ULN, protein (total) \<0.8×LLN or \>1.2×ULN, albumin \<2.5 g/dL, blood urea nitrogen \>30 mg/dL, uric acid \>13.0 mg/dL, creatinine \>2.0 mg/dL, total cholesterol \>300 mg/dL, triglycerides \>2.5×ULN, bilirubin (total) \>2.0 mg/dL, Sodium \<130 mEq/L or \>150 mEq/L, Potassium \<3.0 mEq/L or \>6.0 mEq/L, Chloride \<75 mEq/L or \>126 mEq/L, Calcium \<7.0 mg/dL or \>11.5 mg/dL, Phosphorus \<1.6 mg/dL or \>6.2 mg/dL, alkaline phosphatase \>3×ULN, aspartate aminotransferase \>3×ULN, alanine aminotransferase \>3×ULN, gamma-glutamyl transferase \>3×ULN, glucose \<50 mg/dL or \>350 mg/dL, Magnesium \<1.2 mg/dL or \>3.0 mg/dL.

  Baseline up to Day 14

• Number of Participants With Markedly Abnormal Values of 12-lead Electrocardiogram (ECG)

  Reported data were numbers of participants who met markedly abnormal criteria of 12-lead ECG. A standard 12-lead ECG was performed. The data collected was classified as markedly abnormal values if it met the following criteria: heart rate \<50 bpm or \>120 bpm, QT interval less than or equal to (\<=) 50 msec or greater than or equal to (\>=) 460 msec, QTcF interval \<=50 msec or either of the following conditions was met: observed value \>=500 msec, change from Day 1 Predose \>= 30 msec and observed value \>=450 msec.

  Baseline up to Day 8

• Number of Participants With TEAEs Related to Physical Examinations

  An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with the treatment or study participation. A treatment-emergent adverse events (TEAE) is defined as an AE whose date of onset occurs on or after the start of study drug.

  Baseline up to Day 14

Secondary Outcomes (20)

• AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period

  Day 1 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose

• Cmax: Maximum Observed Plasma Concentration for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period

  Day 1 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose

• AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period

  Day 1 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose

• Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period

  Day 1 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose

• t1/2z: Terminal Disposition Phase Half-life for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period

  Day 1 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose

Study Arms (6)

TAK-906 50 mg; Cohort 1

EXPERIMENTAL

TAK-906 50 milligram (mg) capsules, orally, once daily on Day 1 as Single Dose Period followed by TAK-906 50 mg capsules, orally, twice daily from Day 3 to 7 as Multiple Dose Period.

Drug: TAK-906

TAK-906 Placebo; Cohort 1

PLACEBO COMPARATOR

TAK-906 Placebo capsules, orally, once daily on Day 1 as Single Dose Period followed by TAK-906 Placebo capsules, orally, twice daily from Day 3 to 7 as Multiple Dose Period.

Drug: TAK-906 Placebo

TAK-906 100 mg; Cohort 2

EXPERIMENTAL

TAK-906 100 mg capsules, orally, once daily on Day 1 as Single Dose Period followed by TAK-906 100 mg capsules, orally, twice daily from Day 3 to 7 as Multiple Dose Period. Cohort 2 will be conducted after Cohort 1.

Drug: TAK-906

TAK-906 Placebo; Cohort 2

PLACEBO COMPARATOR

TAK-906 Placebo capsules, orally, once daily on Day 1 as Single Dose Period followed by TAK-906 Placebo capsules, orally, twice daily from Day 3 to 7 as Multiple Dose Period. Cohort 2 will be conducted after Cohort 1.

Drug: TAK-906 Placebo

TAK-906 10 mg; Cohort 3

EXPERIMENTAL

TAK-906 10 mg capsules, orally, once daily on Day 1 as Single Dose Period followed by TAK-906 10 mg capsules, orally, twice daily from Day 3 to 7 as Multiple Dose Period.

Drug: TAK-906

TAK-906 Placebo; Cohort 3

PLACEBO COMPARATOR

TAK-906 Placebo capsules, orally, once daily on Day 1 as Single Dose Period followed by TAK-906 Placebo capsules, orally, twice daily from Day 3 to 7 as Multiple Dose Period.

Drug: TAK-906 Placebo

Interventions

TAK-906 DRUG

TAK-906 capsules.

TAK-906 10 mg; Cohort 3; TAK-906 100 mg; Cohort 2; TAK-906 50 mg; Cohort 1

TAK-906 Placebo DRUG

Placebo capsules.

TAK-906 Placebo; Cohort 1; TAK-906 Placebo; Cohort 2; TAK-906 Placebo; Cohort 3

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• In the opinion of the investigator or sub-investigator, the participant is capable of understanding and complying with protocol requirements.
• The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.
• The participant is a Japanese healthy adult male, aged 20 to 60 years, inclusive, at the time of informed consent.
• The participant weighs at least 50 kilogram (kg) and has a body mass index (BMI) from 18.5 to 25 kilogram per square meter (kg/m\^2), inclusive at Screening.
• A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from the signing of informed consent to 12 weeks (84 days) after the last dose of study drug. The female partner of a male participant should also be advised to use adequate contraception.

You may not qualify if:

• The participant has received any investigational compound within 16 weeks (112 days) prior to the first dose of study drug.
• The participant has received TAK-906 in a previous clinical study or as a therapeutic agent.
• The participant is an immediate family member of or an investigational site employee, or is in a dependent relationship with an investigational site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or may consent under duress.
• The participant has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality, which may impact the ability of the participant to participate in the study or potentially confound its results.
• The participant has a history of any psychiatric disease that would interfere with the evaluation of study drug activity (prolactin concentration) or safety.
• The participant has a history of seizure or tardive dyskinesia.
• The participant has a history of hyperprolactinemia, pituitary adenoma, and/or hypothyroidism.
• The participant has a family history of prolonged QT.
• The participant has undergone previous gastric bypass surgery or currently had a gastric band fitted.
• The participant has dysphagia and/or inability to swallow study medication whole.
• The participant has a known hypersensitivity to any component of the TAK-906 formulation or related compounds.
• The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 2 years prior to the Screening visit, or is unwilling to agree to abstain from alcohol and drugs throughout the study, or has a positive urine test result for drugs of abuse or a positive alcohol screen (urine alcohol test/breath test) result for alcohol at Screening.
• The participant has taken any excluded medication, supplements, or dietary products during the time periods listed in the Excluded Medications, Supplements, and Dietary Products table.
• If male, the participant intends to donate sperm during the course of this study or for at least 12 weeks (84 days) after the last dose of study drug.
• The participant has current or recent (within 24 weeks \[168 days\]) gastrointestinal disease that would be expected to influence the absorption of drugs (that is, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent \[more than once per week\] occurrence of heartburn, or any surgical intervention).

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Sekino Clinical Pharmacology Clinic

Toshima City, Tokyo, Japan

Location

MeSH Terms

Interventions

trazpiroben

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 2, 2017
• Study Start: August 7, 2017
• Primary Completion: October 7, 2017
• Study Completion: October 7, 2017
• Last Updated: January 12, 2021
• Results First Posted: February 18, 2019

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

JP (1)